Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome (ZoMARS)

This study has been completed.

Sponsor:

Wuerzburg University Hospital

ClinicalTrials.gov Identifier:

NCT01348269

First Posted: May 5, 2011

Last Update Posted: June 8, 2017

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The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Men: age over ≥ 18 years or women: age over ≥ 18 years with finished reproductivity according to the following definition:

current or massive dose therapy completed before less than 6 weeks (>7.5mg prednisolon equivalent) with glucocorticoids

patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis

vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia

etiological vague/ambiguous AP-increase

symptomatic renal calculus or nephrocalcinosis within 2 years before V2

recent fracture within the last 3 months independent of the localisation

non consolidated fractures

previous treatment with i.v. bisphosphonates within the last 12 months

previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months